Z-1459-2008

High-Definition 120 MultiLeaf Collimator, Medical charged-particle radiation therapy system; Software Version...

Name: Z-1459-2008 High-Definition 120 MultiLeaf Collimator, Medical charged-particle radiation therapy system; Software Version...
Creator: Varian Medical Systems Oncology Systems
Published: 2008-01-30
License: https://open.fda.gov/license/

Varian Medical Systems, Inc. / initiated 2008-01-30 / Terminated / root cause: software

FDA source

Varian Medical Systems Oncology Systems began a recall of High-Definition 120 MultiLeaf Collimator, Medical charged-particle radiation therapy system; Software Version 7.0; Product Code: H56; Accessory to Medical... on 2008-01-30. The reason FDA records is "Dose Calculation Error: Software anomaly may result in failure of a MLC leaf to reach planned position, potentially resulting in misadministration of dose to a patient". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1459-2008
Status: Terminated
Initiated: 2008-01-30
Posted: 2008-08-02
Terminated: 2010-08-18
Recalling firm: Varian Medical Systems, Inc.
Product: High-Definition 120 MultiLeaf Collimator, Medical charged-particle radiation therapy system; Software Version 7.0; Product Code: H56; Accessory to Medical Linear Accelerator.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: Dose Calculation Error: Software anomaly may result in failure of a MLC leaf to reach planned position, potentially resulting in misadministration of dose to a patient.
Root cause tag: software
FDA root cause: Software design
Action: Consignees were notified by a Medical Device Notification letter sent on 01/29/2008. The letter advised users to cease use of the device until a corrected version of the software is available. A representative will contact users to upgrade the application once the revised software has been validated and released for distribution.
Quantity in commerce: 3 units subject to correction
Distribution: Nationwide Distribution including states of NC, FL and CA.
Product codes and lots: Serial Number 1009.

Product code IYE

K071992Class IIHigh-Definition 120 Multileaf Collimator (Hd120 Mlc)Varian Medical Systems / cleared 2007-08-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)